End-to-end biopharmaceutical services

End-to-end Biopharmaceutical Services

Siemens Healthcare Laboratory offers state-of the-art diagnostic biomarker development and testing services for therapy development programs, from biomarker discovery to global commercialization of diagnostic tests for patient access.
Biomarker discovery research

We help you find the right biomarkers to support your therapy development programs and establish clinical validity. Our discovery team has expertise in working independently or jointly with pharmaceutical partner teams to discover the best biomarkers for specific intended uses. We have technology expertise in mass spectrometry, all aspects of immunoassay development, and molecular diagnostics.

Biomarker assay development for clinical trials

Our rigorous, stepwise biomarker-development process supports development of high-quality biomarker assays which may be offered through our CLIA laboratory in Berkeley, CA, enabling you to deploy qualified tests for your most demanding early- or late-phase clinical trials.

If your biomarkers are developed on our proprietary technology platforms, they may also serve as prototypes for future IVD-kit development projects, reducing technology compatibility risks and costs.

IVD test development and deployment

For patient access, Siemens Healthcare Laboratory offers development of IVD assays for global deployment on our routine platforms including but not limited to the USA, Europe, and Japan.

At Siemens Healthineers, we understand the development, quality, and regulatory requirements for developing IVD blood tests, from single biomarker assays to multi-analyte algorithm assays (MAAA) for highly complex submissions to the most regulated environments, including but not limited to the U.S. FDA, European notified bodies, and Japanese MOH. We will advise you on the best path forward for your diagnostic test commercialization channels.

Reference laboratory testing

Our CAP-accredited, CLIA-licensed laboratory offers high-quality, secure testing services to support your clinical trial needs and beyond, if required.

Our laboratory has extensive clinical trial testing and regulatory experience for small early-stage or large late-stage clinical trials, including multinational clinical trials.

Siemens Healthcare Laboratory also offers a range of proprietary pre-analytical RNA and DNA extraction services from a variety of body fluid types for high-quality yields and a testing service for a range of routine blood tests available on the new Siemens Healthineers laboratory platforms.

Artificial intelligence solutions

Derive more value from diagnostic data obtained from your clinical trials and discover biomarkers for next-generation systems.

Our unique research use only artificial intelligence (AI) modeling technologies can help characterize your patients and increase understanding of clinical trial outcomes.

Siemens Healthcare Laboratory can optimize existing organ-specific models or build new biomarker models for specific therapies and new disease states.